US8579822B2 - Transesophageal ultrasound probe with an adaptive bending section - Google Patents

Transesophageal ultrasound probe with an adaptive bending section Download PDF

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Publication number
US8579822B2
US8579822B2 US11/681,837 US68183707A US8579822B2 US 8579822 B2 US8579822 B2 US 8579822B2 US 68183707 A US68183707 A US 68183707A US 8579822 B2 US8579822 B2 US 8579822B2
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probe
stiffening member
spring plate
bending section
distal
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US20070239022A1 (en
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Edward Paul Harhen
Robert J. Krupa
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Imacor Inc
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Imacor Inc
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Priority to US12/267,860 priority patent/US8172758B2/en
Assigned to WFD VENTURES LLC, AS AGENT reassignment WFD VENTURES LLC, AS AGENT SECURITY AGREEMENT Assignors: IMACOR, INC.
Assigned to IMACOR INC. reassignment IMACOR INC. MERGER (SEE DOCUMENT FOR DETAILS). Assignors: IMACOR LLC
Assigned to IMACOR, INC. reassignment IMACOR, INC. RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS). Assignors: WFD VENTURES LLC, AS AGENT
Priority to US13/437,561 priority patent/US9161740B2/en
Priority to US14/044,526 priority patent/US20150094594A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445—Details of catheter construction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005—Flexible endoscopes
    • A61B1/0051—Flexible endoscopes with controlled bending of insertion part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters

Definitions

  • Transesophageal echocardiography is an ultrasound imaging technique that provides images of the heart for diagnostic and/or monitoring purposes.
  • TEE transgastric short axis view
  • TGSAV transgastric short axis view
  • the ultrasound transducer should ideally be positioned in the fundus of the stomach, with the ultrasound beam aimed through the left ventricle.
  • TEE probes for imaging the TGSAV typically contain mechanical articulation mechanisms to bend the distal end the probe into the desired position in the fundus. Since conventional TEE probes are relatively large (i.e., on the order of 1 ⁇ 2 inch in diameter), the articulation mechanisms can be relatively strong. As a result, when the probe is not perfectly aligned with the desired position, the probe can exert significant forces on the relevant anatomical structures to push the distal end of the probe into the desired location for obtaining the TGSAV. However, when smaller TEE probes are used (e.g., the 5 or 6 mm diameter probes described in U.S. patent application Ser. No. 10/996,816), the probe may not be able to exert enough force to push the distal end of the probe into the desired location.
  • the ultrasound transducer (which is located in the distal end of the probe) should be positioned in the fundus of the stomach, pressed up against the mucosa.
  • the optimal position of the transducer within the fundus depends on a number of parameters including the size of the heart and the position of the heart relative to the fundus. These parameters may vary, for example, with body size, body habitus, and/or anatomical relationships.
  • the optimum position for the transducer within the fundus is referred to hereinafter as “OPF”.
  • the distal end of the probe is inserted in its unbent position into the patient's nose or mouth, down through the patient's esophagus, and into the fundus of the stomach.
  • the operator e.g., a doctor
  • the operator actuates an articulation mechanism to bend the distal end of the probe until it comes into contact with the mucosa lining the superior portion of the fundus, preferably positioning the distal end of the probe at an acceptable position or, most preferably, at the OPF.
  • ultrasound images can be obtained. If, based on the images, it is determined that the distal end is not at an acceptable position or the OPF, the position of the probe may be adjusted to improve the images.
  • the entrance from the esophagus to the stomach is called the lower esophageal sphincter.
  • the lower esophageal sphincter is a relatively stable area because the esophagus itself has a thicker musculature at this point and because the area is supported where it passes through the diaphragm. If the distance from the lower esophageal sphincter to the OPF was the same in all patients, a probe could be designed with its bending joint located at a corresponding distance from the distal tip of the probe. In practice, however, the distance between the lower esophageal sphincter and the OPF (referred to hereinafter as “LOD”) varies from patient to patient. For example, the LOD may typically be between 4-10 cm in adults, and 2-5 cm in children, depending upon body size, body habitus and the position of the heart relative to the diaphragm.
  • TEE probes e.g., 1 ⁇ 2 inch in diameter
  • Conventional large TEE probes have a bending point that is located at a fixed distance from the distal tip of the probe, and can exert significant forces on the relevant anatomical structures to push the distal end of the probe into a suitable location for obtaining the TGSAV.
  • the operator of the device may not perceive the forces as being high due to the mechanical advantage provided by the articulation controls.
  • the distal tip positioning of conventional probes is accomplished by deflecting the relatively compliant lower esophagus and upper stomach cavity with a stiff probe insertion tube and by a powerful bending section within the probe.
  • the probe will often be unable to exert enough force to push the distal end of the probe into a suitable location.
  • Examples of smaller TEE probes include TEE probes for adults that are less than 7.5 mm in diameter, and pediatric TEE probes that are preferably less than 4 mm in diameter (as described in U.S. application Ser. No. 10/996,816)
  • a probe is provided with a transducer disposed in the distal section, and a bending section disposed proximal to the transducer.
  • the proximal portion of the bending section is more flexible than the distal portion of the bending section. This arrangement causes the bending section to conform to the relevant anatomy by first bending near the proximal portion of the bending section, or by bending a greater amount in the proximal portion as compared to the distal portion of the bending section.
  • FIGS. 1A and 1B illustrate the distal portion of an ultrasound probe in its straight and bent positions, respectively.
  • FIGS. 1C and 1D illustrate the distal portion of another ultrasound probe that has a different bending point (in its straight and bent positions, respectively).
  • FIGS. 2A , 2 B, and 2 C illustrate the distal portion of another embodiment of an ultrasound probe that is configured to bend in different locations depending on the anatomy of the patient.
  • FIGS. 3A , 3 B, and 3 C show details of three alternative embodiments for the bending portion of the ultrasound probe of FIGS. 2A-2C .
  • FIGS. 4A and 4B show the distal portion of the ultrasound probe of FIGS. 2A-2C being used in subjects with different sized anatomies.
  • FIGS. 5A , 5 B, and 5 C show isometric, end, and cross-sectional views of a vertebra of a fourth alternative preferred embodiment of the bending portion of the probe of FIG. 2A .
  • FIG. 6 shows an isometric view of the fourth alternative preferred embodiment of the bending portion of the probe of FIG. 2A .
  • FIG. 7 shows a cross-sectional view of the bending portion of FIG. 6 .
  • FIG. 8 shows the spring plate of FIG. 7 .
  • FIGS. 1A-1D illustrate a system for positioning a transducer in a desired anatomical location (e.g., in the OPF, aimed to image the TGSAV of the left ventricle) that can be used even with smaller probes.
  • a set of probes is provided as a kit (not shown), with each probe in the kit designed to bend at a different point along the proximal-distal longitudinal axis of the probe.
  • the operator selects one of the probes from the kit (i.e., the one that is expected to fit best), and uses that probe to obtain the desired images.
  • the kit preferably includes additional probes (not shown) to cover all the bending points that may be needed.
  • a kit may include five probes, with their bending points located 4, 5, 6, 7, and 8 cm from the transducer, respectively.
  • FIGS. 1A and 1B illustrate a first probe 10 from the kit in straight and bent positions, respectively.
  • FIGS. 1C and 1D similarly illustrate a second probe 10 ′ from the kit in straight and bent positions, respectively.
  • the first probe 10 and second probe 10 ′ each include a flexible shaft 12 , which is preferably stiff enough yet flexible enough to permit the operator to position the distal ends 16 of the first probe 10 or second probe 10 ′ into the relevant anatomical structures (e.g., the esophagus) at the desired depth of penetration.
  • the shaft 12 is preferably flexible enough and thin enough to permit placement of the probe within the relevant anatomy, and to permit the shaft to be left in-situ for extended periods of time without causing problems or excessive discomfort. Examples of suitable configurations for the shaft include those found in conventional nasogastric and feeding tubes, as well as transesophageal Doppler monitoring probes such as those made by Deltex Medical Group plc of Chichester, United Kingdom.
  • the components that are proximal to the flexible shaft 12 are well known to persons skilled in the relevant arts, and as such are not described in detail herein.
  • the mechanism for transmitting the operator's actuations of the controls through the shaft to the working end of the probe are also well known and not described herein.
  • a bending section 15 Distally beyond the flexible shaft 12 is a bending section 15 that is much more flexible than the shaft 12 .
  • the bending section 15 may be constructed, for example, using one of the conventional bending mechanisms described below, preferably with a relatively small bending radius (e.g., on the order of 1-21 ⁇ 2 cm).
  • a distal section 16 Distal to the bending section 15 is a distal section 16 that is less flexible than the bending section 15 .
  • An ultrasound transducer 18 is housed within this distal section 16 , preferably mounted transversely, and is used to obtain images (e.g., as described in application Ser. No. 10/996,816).
  • bending section 15 includes a bending point 15 a at the longitudinal center of the bending section 15 , and the bending point 15 a is located at a distance D 1 from the longitudinal center of the transducer 18 .
  • the first probe 10 will bend at the bending section 15 , centered at bending point 15 a , in response to actuation of the bending control, as shown in FIG. 1B .
  • the longitudinal center of the transducer 18 will be positioned out longitudinally at a distance D 1 in a direction at least partly radial to the longitudinal axis of the flexible shaft 12 .
  • FIGS. 1C and 1D illustrate a second probe 10 ′ from the kit, which is identical to the probe of FIGS. 1A and 1B , except that the bending point 15 a of the bending section 15 for the second probe 10 ′ is located at a distance D 2 from the transducer 18 instead of at a distance D 1 .
  • the second probe 10 ′ will bend so that the longitudinal center of the transducer 18 is positioned out longitudinally at a distance D 2 in a direction at least partly radial to the longitudinal axis of the flexible shaft 12 , as shown in FIG. 1D .
  • the operator advantageously obtains the ability to position the transducer at the desired radial distance from the main shaft axis of the probe, to help obtain the desired image.
  • the initial selection of which probe to use may be made using any medically appropriate technique, e.g., based on the size, weight, sex, or age of the patient, or any combination of such characteristics.
  • a more precise estimate of the optimum radial distance maybe obtained using noninvasive imaging techniques such as CT, NMR, or conventional echocardiograms.
  • the distance between the lower esophageal sphincter and the OPF may be determined from the image, and the appropriate probe may be selected from the kit based on that distance.
  • kit of probes it is believed that one disadvantage of using a kit of probes is that the operator may select the wrong probe, in which case the operator will have to either proceed with a sub-optimum probe or withdraw the probe from the patient's body and then insert another probe to obtain the desired image. It is also believed that another disadvantage is that managing inventory for an entire kit of probes is more complicated than managing inventory for a single probe that can be used for most patients.
  • FIGS. 2A-2C illustrate an alternative probe 20 that avoids these possible disadvantages because it can be used for a much wider variety of patients than any individual probe from the above-described kit.
  • the probe 20 has a flexible shaft 22 that is similar to the flexible shaft 12 described above.
  • the components that are proximal to the flexible shaft 22 and the mechanism for transmitting the operator's actuations of the controls to the working end of the probe are well know and are not described herein.
  • a bending section 25 Distally beyond the flexible shaft 22 is a bending section 25 that is preferably more flexible than the shaft 22 , with the proximal portions of the bending section 25 being more flexible than the distal portions of the bending section 25 (i.e., the elastic stiffness of the bending section 25 increases in the distal direction).
  • a distal section 26 Distal to the bending section 25 is a distal section 26 that is preferably less flexible than any portion of the bending section 25 .
  • An ultrasound transducer 28 is housed within this distal section 26 , preferably mounted transversely as described above in connection with FIGS. 1A-1D .
  • the bending control mechanism (not shown, but located proximally to the flexible shaft 22 ) is actuated by the operator, the bending section 25 will begin to flex about a point that is distal and adjacent to the anatomical constraint 24 (e.g., the lower esophageal sphincter).
  • the vertebrae distal to the first unrestrained vertebra flex minimally or not at all initially, and then flex sequentially once all of the more proximal vertebrae have reached their limit of motion in a “domino” effect.
  • images can be obtained using any suitable imaging technique. If, based on the images, it turns out that the distal end is not positioned in the best location for imaging, the position of the probe may require adjustment to improve the images.
  • the probe can be unflexed, advanced further through the lower esophageal sphincter, then re-flexed to achieve a greater LOD (or conversely advanced less to achieve a shorter LOD).
  • imaging plane IP 1 shown in FIG. 2B (imaging plane IP 1 is shown on edge, perpendicular to the page)
  • the operator inserts the probe 20 through the mouth or nose into the esophagus until the longitudinal center of the transducer 28 extends a distance D 1 past the relevant anatomical constraint 24 (i.e., the lower esophageal sphincter).
  • the operator then actuates the control mechanism, which causes the bending section 25 of the probe 20 to bend at a bending point 25 a .
  • the bending section 25 will bend relatively sharply at the lower left corner of the anatomically constraint 24 at the bending point 25 a , and portions of the bending section 25 that are distal to the bending point 25 a will remain relatively straight.
  • the bending control will cause the bending section 25 to bend further until the distal section 26 of the probe 20 comes in contact with the relevant anatomy (e.g., the superior portion of the fundus) as shown in FIG. 2B , with the transducer 28 positioned so that an image along imaging plane IP 1 can be obtained.
  • the operator inserts the probe 20 until the longitudinal center of the transducer 28 extends a distance D 2 past the relevant anatomical constraint 24 and then actuates the control mechanism, which causes the bending section 25 of the probe 20 to bend relatively sharply at the lower left corner of the anatomically constraint 24 at a bending point 25 b until the distal section 26 comes in contact with the relevant anatomy, with the transducer 28 positioned so that an image along imaging plane IP 2 can be obtained.
  • a wide variety of mechanisms may be used to make the bending section 25 more flexible proximally and less flexible distally.
  • FIG. 3A illustrates a first example of a suitable multi-flexibility bending section 25 with a proximal end 25 p connecting to the flexible shaft 22 (not shown) and a distal end 25 d connecting to the distal section 26 (not shown).
  • This embodiment includes a central core 32 with a conventional bending mechanism such as a vertebrae/control wire construction that is commonly used in many medical devices (e.g., ultrasound probes, endoscopes, and catheters).
  • the wires (not shown) to the transducer (not shown) pass through the central core 32 .
  • the central core may be configured, for example, as a vertebrae section (not shown) with a single or multiple pull wires (not shown) to affect the required motion.
  • Suitable designs for the vertebra themselves include pinned, beaded, “wobble washer”, and cut plastic extrusion designs. In all these designs, the vertebrae (not shown) are stacked and designed to provide the desired degree and radius of bending. Examples of suitable bending mechanisms include those disclosed in U.S. Pat. Nos. 5,271,382, 5,143,475, 5,271,381, 5,704,898, and 4,905,666, each of which is incorporated herein by reference in its entirety.
  • the central core 32 is surrounded by a jacket 34 (shown in cross section) with a thickness that gradually increases in the distal direction along the length of the jacket 34 .
  • a jacket 34 shown in cross section
  • the thickness of the jacket 34 is exaggerated with respect to the central core 32 to make the change in thickness more visible.
  • the jacket 34 is preferably much thinner than shown in FIG. 3A .
  • Suitable materials for the jacket 34 include elastomerics and thermoplastics such as C-flex, Kraton, silicone, polyurethane, natural rubber, synthetic rubber, etc.
  • the thickness of the jacket 34 varies between about 0.1 mm and about 1 ⁇ 4 mm at the proximal end 25 p , and increases gradually so that the thickness at the distal end 25 d is about three or four times the thickness at the proximal end 25 p.
  • a central core similar to the central core 32 illustrated in FIG. 3A is surrounded by a jacket with a constant thickness along the length of the alternative central core.
  • the flexibility is decreased in the distal direction by increasing the durometer of the jacket material in the distal direction.
  • This may be implemented, for example, by using a curable material such as polyurethane or silicone and curing the material of the jacket to different degrees at different points along the length of the jacket (e.g., by using heat or ultraviolet light curing or variable catalysts).
  • FIG. 3B illustrates another example of a multi-flexibility bending section.
  • the flexibility of the bending section 25 is decreased in the distal direction in a stepwise manner.
  • This embodiment uses a central core 32 similar to the core describe above in connection with the FIG. 3A embodiment.
  • the central core 32 is preferably completely surrounded by a first jacket layer 35 A (shown in cross section).
  • the distal-most two-thirds of the bending section 25 is then surrounded by a second jacket layer 35 B, and the distal-most one-third of the bending section 25 is then surrounded by a third jacket layer 35 C. Note that while FIG.
  • FIG. 3B illustrates three steps with each of the jacket layers 35 A, 35 B, and 35 C, the number of steps can be varied to provide the desired bending characteristics.
  • the same materials used for the jacket 34 in the FIG. 3A embodiment may be used in this embodiment, and a similar central core 32 may also be used.
  • a suitable thickness for each of the jacket layers 35 A, 35 B, and 35 C is between about 0.1 and about 0.25 mm. Note that the thicknesses of the jacket layers 35 A, 35 B, and 35 C are exaggerated in FIG. 3B with respect to the central core 32 to make the change in thickness more visible.
  • FIG. 3C illustrates yet another example of a multi-flexibility bending section.
  • a wall 37 that is preferably cylindrical or elliptical surrounds a central channel 36 .
  • the wires (not shown) to the transducer (note shown) pass through this central channel 36 .
  • a suitable wall thickness is between about 1 ⁇ 4 mm and about 1 mm, and suitable materials for the wall 37 include polyurethane, nylon, polyethylene, Pebax, plus other polymers and copolymers known to those skilled in the art.
  • Notches 38 are cut into the wall 37 at intervals along the length of the wall 37 .
  • One suitable pattern for the notches is illustrated in FIG. 3C , with the notches 38 on one cross-sectional side of the wall 37 (on the right side of FIG.
  • notch 38 sizes would range from about half the thickness of wall 37 at the proximal end 25 p up to the full thickness of wall 37 at the distal end 25 d , and other notch configurations that provide the desired flexibility gradient will be apparent to persons skilled in the relevant arts.
  • the notches 38 may be filled with a suitable material that does not impede bending (e.g., silicone) and/or the walls 37 may be surrounded by a thin sheath (not shown) of, e.g., C-flex, Kraton, silicone, etc.
  • annular notches may be used that are deeper and or wider at the proximal end 25 p than at the distal end 25 d .
  • constant-sized notches may be used, but the pitch of the constant-sized notches can be varied, i.e., from constant-sized notches that are spaced relatively close together at the proximal end 25 p to a more distant spacing at the distal end 25 d .
  • the alternating notches may be replaced by a helical notch that runs circumferentially around and along the length of the entire bending section 25 , with the width and/or depth of the helical notch decreasing as the helical notch approaches the distal end 25 d of the bending section 25 .
  • a helical notch with a constant width and depth may be used, but the helical pitch of the helical notch is varied, i.e., from a relatively tight helix at the proximal end 25 p to a relatively looser helix at the distal end 25 d .
  • vertical notches that run along the longitudinal length of the bending section 25 maybe cut into the walls 37 , with the width and/or depth of the vertical notches gradually decreasing distally from the proximal end 25 p to the distal end 25 d of the bending section 25 .
  • the changes in flexibility may be designed into the central core 32 by, e.g., varying the dimensions of the individual segments contained within the central core 32 to provide more flexibility at the proximal end 25 p and less flexibility at the distal end 25 d , in a manner that will be apparent to persons skilled in the relevant arts.
  • the bending section 25 includes a braid
  • variations in flexibility may also be provided in the braid by, e.g., painting a triangular pattern of flexible paint into the braid, or by impregnating sequential sections of the braid with different materials. Numerous other alternative ways to make the bending section 25 more flexible proximally and less flexible distally will also be apparent to persons skilled in the relevant arts.
  • the bending section can provide controllable movement and steering of the probe while maintaining a variable stiffness along the longitudinal length of the bending section. This is accomplished with a bending section that has a sheath enclosing a series of axially-arranged vertebrae aligned end to end along the longitudinal length of the bending section. Extending through the spine formed by the vertebrae are a series of spring plates that together have a varying stiffness along the length of the spine, with increasing stiffness towards the distal end of the bending section where the spring plates have a greater stiffness.
  • FIGS. 5A-5C illustrate a vertebra 50 having a body with a longitudinal axis 51 and an oval cross-section in a plane orthogonal to the axis 51 .
  • Vertebra 50 also has a proximal face 52 at a proximal end 53 , and a distal face 54 at a distal end 55 .
  • the distal end 55 has a protrusion 56 and the proximal end 53 has a groove 57 .
  • the protrusion 56 and groove 57 are formed to mate or interface with, respectively, a corresponding groove 57 a and protrusion 56 b of adjacent identically-formed vertebrae 50 a and 50 b disposed, respectively, distally and proximally of the vertebra 50 , as illustrated in FIG. 6 .
  • a spine 58 having a proximal end 58 p and a distal end 58 d , as illustrated in FIG.
  • the interfacing protrusions and grooves of adjacent vertebrae slide against each other, and the engagement between the interfacing protrusions 56 and grooves 57 directs the sliding movement of the vertebra 50 proximate the distal end 58 d in radial directions 59 a and 59 b .
  • the spine 58 is covered by a sheath 60 (shown in part) to form a bending section 125 having a proximal end 125 p with a proximal end vertebra 50 p , and having a distal end 125 d with a distal connector 61 .
  • the proximal end 125 p of the bending section 125 engages the distal portion of a flexible shaft (not shown) similar to the flexible shaft 22 illustrated in FIG. 2A .
  • the distal end 125 d of the bending section 125 engages the proximal portion of a distal section (not shown) similar to the distal section 26 illustrated in FIG. 2A .
  • the vertebrae 50 and distal connector 61 can be made of any hard plastic (e.g. polycarbonate, ABS, etc.).
  • the sheath 60 is preferably made from an elastomeric biocompatible material such as Kraton, polyurethane, silicone, etc.
  • the sheath 60 fits over the vertebrae 50 so as to hold each vertebrae 50 adjacent to each other and to maintain a unified spine 58 structure.
  • the use of the sheath 60 simplifies the manufacture of the spine 58 because each adjacent vertebrae 50 can be assembled next to each other and held in position without the use of a direct connection between each adjacent vertebrae 50 , by using the sheath 60 to prove a enveloping structure connecting the vertebrae 50 together to form the spine 58 .
  • the sheath 40 can be a shrink wrap that is disposed around spine 58 , and shrunk to hold the vertebrae 50 together in spine 58 .
  • each vertebra 50 that extend longitudinally along the entire length of the bending section 125 (when the vertebrae are aligned to form the bending section 125 ) until reaching the distal connector 61 where the channels 62 merge into a single channel 63 extending through the distal connector 61 .
  • Each of the channels 62 guide a wire 64 that slidably extends through the bending section 125 to connect the proximal end of the probe (not shown) to the distal end of the probe (not shown).
  • the wires 64 are moved at the proximal end of the probe in the direction of the longitudinal axis 51 to cause the bending section 125 to move in either of the two radial directions 59 a or 59 b .
  • the wires 64 may be made of any material with a suitably high tensile strength and low stretch, (e.g., plastic, or metal such as stainless steel).
  • Also formed in each vertebra 50 is a channel 67 extending through the spine 58 to guide the wiring connecting the ultrasound transducer 28 distal of the spine 58 to ultrasound equipment proximal to the spine 58 , and it most preferably a ribbon cable such as that disclosed in U.S. Provisional Patent Application No. 60/743,702, filed Mar. 23, 2006, which is incorporated by reference in its entirety.
  • a channel 65 extends longitudinally through each vertebra 50 along the entire length of the bending section 125 (when the vertebrae are aligned to form the bending section 125 ) until reaching the distal connector 61 where the channel 65 merges into the single channel 63 .
  • the channel 65 preferably has a rectangular cross-sectional shape guiding one or more spring plates 66 through most of the longitudinal length of the bending section 125 .
  • the spring plates 66 are preferably made of a material with a high elastic limit such as spring steel (e.g. stainless steel spring steel).
  • the spring plates 66 are also preferably formed to naturally retain a longitudinally straight form, and with a stiffness that provides a resistance to bending forces.
  • the spring plates 66 provide a structure onto which each vertebrae can be installed by sliding each vertebra 50 over an end of the spring plates 66 until forming the completed assembly of the spine 58 and, after all the vertebrae are in place, the spine assembly can be covered and held together by the sheath 60 .
  • a first spring plate 66 a is disposed within the channel 65 and extends from the proximal end vertebra 50 p to the distal connector 61 .
  • the first spring plate 66 a is slidably disposed within the channel 65 extending through the vertebrae 50 and fixedly connected to the distal connector 61 at the channel 65 extending through the distal connector 61 .
  • a shorter second spring plate 66 b is disposed adjacent and parallel to the first spring plate 66 a .
  • the second spring plate 66 b is slidably disposed within the channel 65 extending through the vertebrae 50 and fixedly connected to the distal connector 61 at the channel 65 extending through the distal connector 61 .
  • a third spring plate 66 c shorter than the second spring plate 66 b , is disposed adjacent and parallel to the second spring plate 66 b .
  • the third spring plate 66 c is slidably disposed within the channel 65 extending through the vertebrae 50 and fixedly connected to the distal connector 61 at the channel 65 extending through the distal connector 61 .
  • the radial-directed movement of the vertebrae 50 disposed around the first and second spring plates 66 a and 66 b is resisted by the combined stiffness of the first and second spring plates 66 a and 66 b .
  • the radial-directed movement of the vertebrae 50 disposed around the first, second and third spring plates 66 a - 66 c is resisted by the combined stiffness of the first, second and third spring plates 66 a - 66 c .
  • the combined stiffness of the first and second spring plates 66 a and 66 b is greater than the stiffness of the first spring plate 66 a
  • the combined stiffness of the first, second and third spring plates 66 a - 66 c is greater than the stiffness of the first spring plate 66 a or the combination of the first and second spring plates 66 a and 66 b .
  • adjacent spring plates 66 instead of adjacent spring plates 66 providing a variable stiffness or flexibility to the bending section 125 , a single spring plate can be used that has material properties that provide a varying stiffness along the length of the spring plate, such as a combination of two or more materials where a stiffer material of the combination dominates the combination in the stiffer portions of the spring plate.
  • the adjacent spring plates 66 can be replaced with a single spring plate that has a thickness that varies along the length of the spring plate, with the varying thickness providing a variable stiffness to the spring plate.
  • the adjacent spring plates 66 can be replace by one or more spring plates that have shapes that provide a variable stiffness, such as a single spring plate that has a constant thickness along its length but tapers in its width to have a narrower cross-sectional width that reduces stiffness of the spring plate.
  • the adjacent spring plates 66 can be replaced with one or more spring plates that are structurally modified to provide a variable stiffness along the length of the spring plate, such as by constructing the spring plate to have one or more predetermined holes or notches in or through the surface of the spring plate to vary the stiffness of the spring plate along its length.
  • alternative stiffening members e.g., one or more metal or plastic rods or bars
  • FIG. 4A illustrates the relevant anatomic structures for an average size person, including the esophagus 41 , the lower esophageal sphincter 42 , the stomach 43 , the fundus 44 , the heart 45 , and the left ventricle 46 ; and FIG. 4B illustrates the corresponding structures in a larger person (labeled with corresponding reference numbers 41 ′- 46 ′).
  • the distal end 26 of the probe 20 can be easily positioned at the OPF, where the probe can be used to acquire images of the desired imaging planes IP 1 and IP 2 , respectively.
  • a relatively sharp bend is anatomically appropriate because the esophagus 41 is relatively straight and the stomach cavity is large, and a sharp bend facilitates improved contact with the superior portion of the fundus 44 .
  • This stands in contrast to conventional ultrasound probes, endoscopes, and catheters that have traditionally been designed with bending mechanisms designed to bend smoothly and gradually, so as to provide easier their passage through the various lumens and cavities of the body.
  • the multi-flexibility bending section is described above in the context of thin TEE probes, it can also be used with conventional 1 ⁇ 2 inch diameter TEE probes, to make it easier to position the probe at the OPF.
  • the probes may also be used to obtain other transesophageal images, and may even be used in cavities other than the esophagus, outside of the body when access is limited, or in non-medical applications.
  • the multi-flexibility bending section may also be incorporated into probes, endoscopes, or catheters in non-ultrasound medical applications, and may even be used in non-medical uses where similar bending characteristics are desirable.
  • the multi-flexibility bending section can be used with an optical probe, with a sensor that is acoustic, electrical, or magnetic, or with a device that emits or detects radiation or vibrations.

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US11/681,837 2006-03-06 2007-03-05 Transesophageal ultrasound probe with an adaptive bending section Active 2030-02-18 US8579822B2 (en)

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US11/681,837 US8579822B2 (en) 2006-03-06 2007-03-05 Transesophageal ultrasound probe with an adaptive bending section
US12/267,860 US8172758B2 (en) 2006-03-06 2008-11-10 Transesophageal ultrasound probe with an adaptive bending section
US13/437,561 US9161740B2 (en) 2006-03-06 2012-04-02 Probe with an adaptive bending section
US14/044,526 US20150094594A1 (en) 2006-03-06 2013-10-02 Transesophageal ultrasound probe with an adaptive bending section

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WO2007103872B1 (en) 2008-02-28
US20150094594A1 (en) 2015-04-02
US20070239022A1 (en) 2007-10-11
CN102090903A (zh) 2011-06-15
CN101437439A (zh) 2009-05-20
CN101437439B (zh) 2011-03-09
WO2007103872A3 (en) 2008-01-10
CA2644967A1 (en) 2007-09-13
EP1996064A2 (en) 2008-12-03
JP2009528910A (ja) 2009-08-13

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